Recombinant bivalent bacterial vaccine for the prevention of mastitis

Abstract

This invention concerns a recombinant vaccine for the prevention of mastitis in milking mammals, particularly cows, and to methods for the production and use of the vaccine. The vaccine against mastitis is made from an E. coli cell that has been genetically engineered, or transformed, to contain and express an antigen from one or more of the pathogens responsible for causing mastitis.

What is claimed is:  
     
         1 . A vaccine comprising: 
 (a) inactivated, transformed  E. coli  cells which have expressed a gene coding for an antigen from a pathogen associated with mastitis; and,    (b) a pharmacological carrier.    
     
     
         2 . The vaccine of  claim 1 , further comprising an adjuvant.  
     
     
         3 . The vaccine of  claim 2 , wherein the adjuvant is saponin.  
     
     
         4 . The vaccine of  claim 3 , wherein the saponin adjuvant is QS-21.  
     
     
         5 . The vaccine of  claim 1 , wherein the antigen is from  Staphylococcus aureus.    
     
     
         6 . The vaccine of  claim 5 , wherein the antigen is a fibronectin binding protein.  
     
     
         7 . The vaccine of  claim 1 , wherein the antigen is from Streptococcus.  
     
     
         8 . A vaccine comprising: 
 (a) inactivated, transformed  E. coli  cells which have expressed a gene coding for fibronectin binding protein in a biologically effective concentration of from about 05 to about 2.0 mg/ml;    (b) a saponin adjuvant; and,    (c) a pharmacological carrier.    
     
     
         9 . The vaccine of  claim 8 , wherein the saponin adjuvant is QS-21.  
     
     
         10 . A vaccine produced according to the process comprising the steps of: 
 (a) culturing  E. coli  cells transformed with a gene coding for an antigen from a pathogen associated with mastitis;    (b) expressing the gene coding for the antigen to produce the antigen;    (c) recovering the  E. coli  cells and expressed antigen;    (d) inactivating the recovered  E. coli  cells;    (e) incorporating the inactivated  E. coli  cells and expressed antigen in a biologically effective concentration in an appropriate pharmacological carrier.    
     
     
         11 . The vaccine of  claim 10 , further comprising the step of admixing an adjuvant in the pharmacological carrier.  
     
     
         12 . The vaccine of  claim 11 , wherein the adjuvant is saponin.  
     
     
         13 . The vaccine of  claim 12 , wherein the saponin adjuvant is QS-21.  
     
     
         14 . The vaccine of  claim 10 , further comprising the step of admixing a preservative in the pharmacological carrier.  
     
     
         15 . The vaccine of  claim 14 , wherein the preservative is phenol or glutaraldehyde.  
     
     
         16 . The vaccine of  claim 10 , wherein the pharmacological carrier is a saline solution.  
     
     
         17 . The method of vaccinating a cow against mastitis, comprising administering to the cow an effective amount of the vaccine of any of claims  1 - 9 .